Accepted for Publication: October 30, 2014.
Published Online: December 29, 2014. doi:10.1001/jamaneurol.2014.3780.
Study concept and design: Nash, Griffith, Muraro, Openshaw, Sayre, Arnold, Kraft, Bowen.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Nash, Griffith, Spychala, McConville.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Spychala, McConville.
Obtained funding: Nash.
Administrative, technical, or material support: Nash, Racke, Popat, Sayre, Stüve, Arnold, Harris, Phippard, Georges, Kraft.
Study supervision: Nash, Racke, Griffith, Stüve, Arnold, Kraft.
Conflict of Interest Disclosures: Dr Nash received a grant from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)/Immune Tolerance Network (ITN) and nonfinancial support from Baxter. Dr Hutton received grants and personal fees from Biogen Idec, EMD Serono, Genzyme, Novartis, and Teva Neuroscience; personal fees from Bayer and Pfizer; and grants from Accorda, Avanir, Hoffman LaRoche, and Opexa Therapeutics. Dr Racke received grants from National Multiple Sclerosis Society and Teva and was a consultant for Biogen Idec, Novartis, Questcor, and Revalesio. Dr Popat received a grant from NIAID, NIH/ITN. Dr Devine has received grants from the National Heart, Lung, and Blood Institute and the National Cancer Institute. Dr Stüve has received grants from Teva Neuroscience, is an associate editor for Clinical & Experimental Immunology, serves on the editorial board for Multiple Sclerosis Journal, is the managing editor for Therapeutic Advances in Neurological Disorders, and serves on data monitoring committees for Pfizer and sanofi-aventis. Dr Arnold receives payments to NeuroRx from NIAID and NIH/ITN and personal fees from Acorda, Biogen Idec, Genzyme, Hoffman-La Roche, Innate Therapeutics, Medimmune, Mitsubishi, Novartis, Stem Cells Inc, and Teva. Dr Wundes receives grants and personal fees from Biogen Idec and personal fees from Acorda, Med-IQ (medical education organization), Multiple Sclerosis Association (nonprofit), and Teva. Dr Kraft is a member of Axon Council for Acorda. Dr Bowen receives grants from N01AI15416, NIH/NIAID; personal fees from Pfizer and Teva Neuroscience; personal fees and research contracts from Biogen, EMD Serono, and Novartis; and research contracts from Genentec, Genzyme, GlaxoSmithKline, Medimmune, and sanofi-aventis. No other disclosures were reported.
Funding/Support: This work was sponsored by the Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases (DAIT-NIAID),NIH, and was conducted by the ITN (grant N01 AI015416), and the DAIT-NIAID funded statistical and clinical coordinating centers (contracts HHSN272200800029C and HHSN272200900057C). Baxter Healthcare Corporation supplied the Isolex 300i Magnetic Cell Selection System machines, Disposable Sets, and CD34 Reagent Kits used for the HALT-MS clinical trial to DAIT, NIAID, without charge.
Role of the Funder/Sponsor: The funding organization and sponsor, DAIT, NIAID, NIH, participated in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and the decision to submit the manuscript for publication.
Disclaimer: The opinions expressed are those of the authors and do not represent the position of the NIAID, NIH, or US government. Dr Stüve is an associate editor for JAMA Neurology but was not involved in the editorial review or decision to accept the manuscript for publication.
Additional Contributions: We thank the patients and their families for their participation in this study and the research nurses, clinical coordinators, and data technicians for their many essential contributions to patient care and the conduct of the protocol. Noha Lim, PhD (Immune Tolerance Network), contributed statistical analysis for eFigure 2 in the Supplement. There was no financial compensation.